Agile Medical Device Development: Do or Don’t?
Organizational aspects
In this article we are highlighting two important differences between traditional organizations and agile organizations. These two aspects demonstrate that agile requires a different view and therefore a different approach to the same problem. These aspects are:
- Resource allocation
- Organizational structure
This article is the first of three articles explaining the differences between a traditional way of product development and a more agile way of product development. These articles are based on a survey we did on agile product development with medical device companies.
1. Resource Allocation
Imagine you are the project manager on a large project and need an additional resource to pick up extra work. You probably must go through some kind of approval process, because someone – probably a departmental manager – must make a person available and that is difficult because everybody is busy on other projects.
FTE versus Individual
What we see happening a lot in organizations is that there is no dedicated person available for the request at hand. As a result, an FTE (Full Time Equivalent) is made available, basically several part time people: John is available on Mondays, Lucy on Tuesdays and Thursdays. Tony can handle the Wednesday and Anna will cover the Fridays.
In fact, what happens is that you as a project manager receive an arm from one person, a couple of legs from another, the body from someone else and the head from a fourth person.
Basically, you end up with an additional problem in stead of a solution. These people must work together, must communicate and hand over tasks. You were probably asking for an individual and not an FTE. In addition, for knowledge workers – and much of our work is knowledge related – it is extremely hard to switch between multiple project contexts. It creates waste.
The waste of project switching
Gerald Weinberg introduced a rule of thumb to calculate the waste caused by project switching: With every additional project, 20% waste is added – view graph below.
Often management thinks the resource request is adequately covered and they calculate from a productivity point of view as if there is a dedicated FTE allocated. But in fact, they have created more problems than they can imagine. Not only the project that the resource is newly allocated to is negatively impacted from a productivity point of view. In addition, the other projects that these 4 resources are working on simultaneously are also negatively impacted! The root cause is not having a dedicated individual assigned to the project/team.
The result is that the overall productivity will decrease instead of increase.
Dedicated resources and teams
Agile suggests a completely different approach and the above issue with fragmented resources is one of the reasons. Dedicated teams and dedicated resources in these teams are a pre-condition to aim for high velocity and high quality output of teams.
Teams can meet their responsibilities only through constant communication and collaboration, and through fast, effective, and empowered decision-making. Relationships within the team are therefore based on trust, facilitated by a common mission, iteration goals, and team objectives. This requires teams to stay together for a longer period with dedicated team members.
Prioritization
In an organization where resources are spread across multiple projects, the need to make hard decisions about priorities is less present. The symptom usually heard is that projects take forever to finish. The root cause is that people and teams are not dedicated working on a single objective.
When teams and resources are dedicated, management needs to step up and make clear decisions about priorities. More importantly, they must make decisions on what work not to do or do later, when resources become available.
2. Organizational structure
Traditionally, organizations are functionally structured. In such an organization, software developers work with software developers, testers work with testers, systems engineers and architects work with each other and operations work with themselves. This works well for people management and it’s easier to control and optimize individual silos.
However, the value delivered to a customer doesn’t flow quickly, as it must go through all of the silos. Value delivery is inhibited by hand-offs and delays between the different silos. Political boundaries and misalignment in targets and goals across the silos prevent collaboration. In addition silos may encourage geographic distribution of functions which also makes communication across silos more difficult especially when different time zones are involved. The daily involvement of managers and project managers is necessary to move the work across the silos. As a result, progress is slow.
The Agile organization – Team of teams
Instead the Scaled Agile Framework (SAFe®) suggests setting up a cross-functional organization that optimizes the full value stream facilitating the flow of value.
To enable this cross-functional organization to deliver value, it has all the resources – everyone and everything – to define, deliver and operate solutions. In addition, it is self-organizing and self-managing and doesn’t require the daily task and project management no longer. As a result, value flows more quickly, with a minimum of overhead. SAFe calls this an Agile Release Train.
Agile Teams
The Agile organization is built on Agile teams, which are also cross-functional and consist of 5 to 11 people, who define, build, test, deploy and deliver an increment of the solution in a short iteration (every 2 to 4 weeks).
Agile Teams do not operate independently. They plan together, integrate, demo, deploy and release together, and learn together. All teams operate within a common framework that governs and guides them as one organization – The Agile Release Train.
The above findings are based on a recent survey among medical device development professionals, where we tried to find an answer to the question “Agile Medical Device Development: Do or Don’t”. In a follow-up of 3 articles we provide 6 aspects of working agile that differ significantly from working project-based. This article is the first one, focusing on the organizational differences compared to traditional organizations. Watch our web site for the next 2 articles.
